Z-1468-2022 Class II Ongoing
FDA device recall Z-1468-2022 was initiated by Paragon 28, Inc. on May 26, 2022 and is designated Class II. Reason for recall: Due to Titanium plasma coating not present implant. The recall status is ongoing. Affected quantity: 9 implants.
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2022
- Initiation Date
- May 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 implants
Product Description
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Reason for Recall
Due to Titanium plasma coating not present implant.
Distribution Pattern
U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
Code Information
Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202